—#108483

Product

ARTISTE or ONCOR Linear Accelerators in combination with 160MLC (Multi Leaf Collimator). Linear Accelerators that may be affected are: ARTISTE MV System; ONCOR Avant Garde ONCOR Impression ONCOR Impression Plus ONCOR Expression. Manufactured by Siemens AG, Medical Solutions, Kemnath, Germany; Registered by Siemens Medical Solutions, Concord, CA. ARTISTE and ONCOR family of Linear Accelerators are used to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. Product Model with Part Number: ARTISTE MV System, 8139789; ONCOR Avant Garde, 5863472; ONCOR Impression, 5857920; ONCOR Impression, Plus 5857912; ONCOR Expression, 7360204; ONCOR Expression, 7360717. ARTISTE and ONCOR family of Linear Accelerators are used to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.

FDA product code: IYE — Accelerator, Linear, Medical
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K072486, K092145
Affected lot / code info: Product Model with Part Number: ARTISTE MV System, 8139789; ONCOR Avant Garde, 5863472; ONCOR Impression, 5857920; ONCOR Impression, Plus 5857912; ONCOR Expression, 7360204; ONCOR Expression, 7360717

Why it was recalled

Siemens became aware of a potential safety risk related to the behavior of the 160 MLC when using the "Motion Stop" button followed by "Reset" several times during the treatment of one beam or one segment (issue 1). Additionally, there may be a potential for collision if the operator does not ensure clearance of the extended flat panel positioner for all gantry rotation angles (issue 2).

Root cause (FDA determination)

Labeling design

Action the firm took

Siemens sent a Safety Advisory Notice with Update to all affected customers. The notice informed the customers of the risk of pressing the Motion Stop button repeatedly during treatment. Work Steps were provided for customers to follow.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 4040 Nelson Ave, Concord, California 94520-1200

Distribution

Distribution pattern: Worldwide Distribution - USA including the states of CA, DE, FL, IL, KY, LA, MA, MI, NE, NJ, NY, OH, PA, SD, TN, UT, WI, and WV

Timeline

Recall initiated: 2012-04-03
Posted by FDA: 2012-05-07
Terminated: 2012-07-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #108483. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.